方案摘要
方案下载| 应用领域 | 其他 |
| 检测样本 | 其他 |
| 检测项目 | |
| 参考标准 | CFR |
21 CFR Part 11 established requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and equivalent substitutes for paper records and traditional handwritten signatures. Commonly known as Part 11, it requires Food and Drug Administration (FDA)-regulated industries, including medical device manufacturers, drug makers, biotech companies and biologics developers, to have validation documentation and implement controls such as audit trails and electronic signatures. The requirements apply to software and systems involved in processing electronic data that are required to be maintained by or used to demonstrate compliance with FDA predicate rules.
Compliance with regulatory requirements is critical for a business. It is often
regarded as something that can add significant cost to the company but with
the acquisition of a chromatography data system (CDS) that provides all of the
necessary functionality built-in to one package, that is easy to use, the effort
required to achieve compliance with 21 CFR Part 11 is significantly reduced.
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高压离子色谱Inuvion快速测定生活饮用水中的亚氯酸 盐、溴酸盐、氯酸盐、二氯乙酸和三氯乙酸
Thermo Fisher Scientific iCAP TQe ICP-MS/MS测定土壤和沉积物多种元素
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